Akili has released top line results from its STARS-ADHD-Adult pivotal clinical trial, which evaluated the efficacy and safety of Akili’s EndeavorRx (AKL-T01) in adults with ADHD. EndeavorRX is a video-game based treatment for ADHD, currently approved by the FDA for use by children aged 8-12. The recent results suggest the product’s suitability for use by adults, potentially opening up a new market opportunity for Akili.

Why it's notable:

The top line results of the FDA pivotal trial, which enrolled 221 adults with inattentive or combined-type ADHD, are promising. Over 80% of participants experienced a clinically meaningful improvement in attention, and more than one third no longer exhibited an attention deficit after the 6 weeks intervention which involved using the game based program on a mobile device at home. 

Of particular note, improvements observed in attention among the participants, as determined by the Test of Variables of Attention-Attention Comparison Score computerised test, were almost seven times greater than improvements observed for the pivotal clinical trial of children aged 8 to 12 (6.5 point improvement versus 0.9 point respectively). Results did not differ significantly if participants were also on prescription medication for ADHD or not. Furthermore, nearly half of participants met a prespecified threshold for clinically meaningful improvement in their quality of life, and the device was well tolerated with no serious adverse events reported.

Industry Implications: 

The rate of adults being diagnosed with ADHD in the US has grown significantly in recent years, with millions of adults experiencing the condition. There is a growing demand among adults with ADHD for safe, effective, and accessible non-drug treatments, it is increasingly recognised that current available options are not working, and/or are not available. According to the company’s Chief Medical Officer, Scott Kollins, Akili’s game based treatment could fill a gap in the market for a non-drug therapy for adults with ADHD.

The positive results come amid a rocky period for Akili. After experiencing rapid growth in recent years, 2023 has seen Akili announce significant layoffs and draw back their plans to expand into other therapeutic areas. The company generated just $323,000 in revenues for 2022 against operating expenses of $90 million, and the stock price hit an all time low of 97 cents at the end of 2022, down from $14 the previous September. However, following the release of these impressive results on Wednesday, the company’s stock price went up 37% overnight. Akili plans to submit results to the FDA later this year, approval from which would open up a new market space for Akili and could help to reverse declining revenues seen this year. Given the larger industry trends of layoffs and declining revenues in DTx companies in recent times, it is hopeful to see potential for reversing these downward trends, and may help to reduce fears and concerns around DTx among industry stakeholders.